Regulatory Affairs Director

🕒 Junho 2

🏄 California – Remoto

🏄 California – Remote

💵 $150.000 - $175.000 / ano

⏰ Tempo Integral

🔴 Especialista

🚔 Conformidade

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VitalConnect

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2011

📡 Telecomunicações

Healthcare • Telecommunications • Technology

A VitalConnect é uma empresa de tecnologia em saúde que se especializa em soluções de monitoramento remoto de pacientes, particularmente para saúde cardíaca. Seu produto principal, o VitalPatch RTM, permite o streaming em tempo real de sinais vitais, permitindo que os prestadores de saúde monitorem a condição dos pacientes no conforto de suas casas. A VitalConnect é especialmente relevante no contexto da COVID-19, pois suas tecnologias facilitam o monitoramento seguro dos pacientes enquanto minimizam a exposição dos cuidadores. A abordagem inovadora da empresa em telemedicina a tornou um jogador-chave na otimização do cuidado ao paciente.

Descrição

• Responsible for regulatory affairs activities such as regulatory submissions, registrations and listings. • Assure compliance with applicable medical device regulations per jurisdiction, guidance and standards. • Assist in creation and maintenance of regulatory files. • Assist with post-market activities. • Write, analyze, and edit technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including device submissions in USA, Europe and other countries. • Work with other departments and communicate the submission requirements when documents are needed for regulatory submission. • Maintain regulatory files. • Maintain and update regulatory authorizations, such as 510(k)s, medical device licenses, certificates, and CE Technical Files for EU, etc. • Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports. • Support approval in other regions as required. • Assist in preparing response to regulatory authorities’ questions within assigned timelines. • Stay abreast of regulatory procedures and changes in regulatory climate. • Assess device related incidents/complaints for medical device reporting requirements. • Compile and submit reportable events to relevant regulatory authorities in timely manner. • Handle recalls and field actions, if required. • Review and create product labels and review promotional material for compliance with applicable regulations and technical standards. • Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.

🎯 Requisitos

• Bachelor’s degree in Engineering or Science or related scientific discipline. • 4 years minimum experience in a medical device environment • Working knowledge of regulations, standards and guidelines related to regulatory affairs • Scientific knowledge, must be able to digest complex data while keeping the big picture through good analytical skills • Excellent written and verbal communication skills with the ability to listen, articulate and advocate • Proactive, high performance, result oriented and manage projects with ethical integrity • Technical system skills (e.g. MS office applications, databases, efficient online research) • Manage multiple projects and deadlines • Ability to identify compliance risks and escalate when necessary • Demonstrate both creative and critical thinking skills.

🏖️ Benefícios

• medical • dental • 401K retirement plan